NCT05719493

Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)

Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Primary Care Intervention in Fibromyalgia and Chronic Fatigue Syndrome: SYNCHRONIZE + Mixed Methods Study Protocol.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.

Detailed description

The investigators will perform a mixed study through a randomized clinical trial in Catalonian Primary Care with patients diagnosed of Fibromyalgia (M79.7) or both Fibromyalgia and Chronic Fatigue Syndrome (G93.3). The control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). The intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. In both groups, quality of life (EuroQol-5D), as well as MFI, VAS pain, PSQI, erMEDAS-17, BRIAN, REGICOR-Short, FIQR and HADs questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. Food intake, body composition, resistance and strength will also be evaluated. The effect size will be calculated using Cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. In addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.

Conditions

• Fibromyalgia
• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
OTHER	multicomponent treatment	The intervention to be evaluated consists of 4 group sessions carried out in two weeks, 6 hours per week divided in 2 days (a total of 12 hours), of active education in nutrition, chronobiology and physical exercise in people diagnosed with Chronic Fatigue Syndrome and Fibromyalgia.

Timeline

• Start date: 2021-10-04
• Primary completion: 2024-05-31
• Completion: 2025-12-01
• First posted: 2023-02-09
• Last updated: 2024-12-18

Locations

1 site across 1 country: Spain